Osteoarthritis, KneePhase 4OA-bi-BlindNCT03110679
Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid
A Phase 4 study testing injection of autologous bone marrow concentrate and injection of hyaluronic acid. in people with Osteoarthritis, Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- injection of autologous bone marrow concentrate and injection of hyaluronic acid.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2016to May 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients, aged between 18 and 75 years;
- Bilateral symptomatic knee osteoarthritis (Kellgren-Lawrence grade 1-4);
- Failure after two months of conservative treatment;
- Capacity and consent of patients to participate actively in the rehabilitation protocol, follow-up clinic and radiology protocol;
- Signature of informed consent.
Who cannot join
- Patients incapable of discernment;
- Patients with malignancy
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients with metabolic disorders of the thyroid;
- Patients belonging abuse of alcohol, drugs or medications;
Show all 9Show fewer
- Patients with misalignment of the lower limbs than 10 °;
- Body Mass Index> 40;
- Patients with a history of trauma or intra-articular infiltration of therapeutic substances within 6 months prior to treatment.
Trial locations and contacts
1 site in 1 country.
About this study
OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.
Read the detailed description
a randomized, controlled, double-blind study and we will be evaluated and compared the clinical and radiological results of concentrated autologous bone marrow against the hyaluronic acid in patients with bilateral knee osteoarthrosis . In randomization, one knee will be treated with autologous bone marrow concentrate and other knee with hyaluronic acid, then every patient is considered both in control and treatment group, limiting the heterogenity between groups and will not be informed of the knee assigned to the treatment group.
- Conditions
- Osteoarthritis, Knee
- Being tested
- injection of autologous bone marrow concentrate, injection of hyaluronic acid.
- Keywords
- osteoarthritis, autologous bone marrow concentrate
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of autologous bone marrow concentrateBiological
injection of hyaluronic acid.Biological
| Study group | Role | What they receive |
|---|---|---|
| autologous bone marrow concentrate | Experimental | concentration of bone marrow taken from the patient's right tibia using Bio-MAC® suction catheter, company Biologic Therapies, Inc., and concentrated by centrifuge Bio.SPINTM Magellan®, company Biologic Therapies , Inc., and its injection in the intra-articular. Receives: Biological: injection of autologous bone marrow concentrate |
| hyaluronic acid. | Experimental | single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control. Receives: Biological: injection of hyaluronic acid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC)-Subjective score
Clinical improvement, measured by the change in scores IKDC Subjective
Measured: Time Frame: 6 months
Secondary outcomes (2)
International Knee Documentation Committee (IKDC)-Subjective score
Stability of the initial clinical improvement between 6 and 24 months
Measured: Time Frame: 1,3,6, 12, 24 months evaluation
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Stability of the initial clinical improvement between 6 and 24 months of the KOOS pain score
Measured: Time Frame: 1,3,6, 12, 24 months evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start23 May 2016
- Primary completionNov 2016
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- autologous bone marrow concentrate vs. hyaluronic acid.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110679
- Sponsor's protocol ID
- OA-bi-Blind
- Acronym
- OA-bi-Blind
- Status last verified
- Feb 2021
- First submitted
- 30 Mar 2017
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid
- ClinicalTrials.gov ID
- NCT03110679
- Acronym / sponsor ID
- OA-bi-Blind / OA-bi-Blind
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, autologous bone marrow concentrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 23 May 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.
Detailed description
a randomized, controlled, double-blind study and we will be evaluated and compared the clinical and radiological results of concentrated autologous bone marrow against the hyaluronic acid in patients with bilateral knee osteoarthrosis . In randomization, one knee will be treated with autologous bone marrow concentrate and other knee with hyaluronic acid, then every patient is considered both in control and treatment group, limiting the heterogenity between groups and will not be informed of the knee assigned to the treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- autologous bone marrow concentrate vs. hyaluronic acid.
| Arm | Type | Receives |
|---|---|---|
| autologous bone marrow concentrate | Experimental | Biological: injection of autologous bone marrow concentrateconcentration of bone marrow taken from the patient's right tibia using Bio-MAC® suction catheter, company Biologic Therapies, Inc., and concentrated by centrifuge Bio.SPINTM Magellan®, company Biologic Therapies , Inc., and its injection in the intra-articular. |
| hyaluronic acid. | Experimental | Biological: injection of hyaluronic acid.single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients, aged between 18 and 75 years;
- Bilateral symptomatic knee osteoarthritis (Kellgren-Lawrence grade 1-4);
- Failure after two months of conservative treatment;
- Capacity and consent of patients to participate actively in the rehabilitation protocol, follow-up clinic and radiology protocol;
- Signature of informed consent.
Key exclusion criteria (9 listed)
- Patients incapable of discernment;
- Patients with malignancy
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients with metabolic disorders of the thyroid;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of autologous bone marrow concentrate | Biological | autologous bone marrow concentrate |
| injection of hyaluronic acid. | Biological | hyaluronic acid. |
Primary outcome
International Knee Documentation Committee (IKDC)-Subjective score
Time frame: Time Frame: 6 months
Clinical improvement, measured by the change in scores IKDC Subjective
2 secondary outcomes
International Knee Documentation Committee (IKDC)-Subjective score
Time frame: Time Frame: 1,3,6, 12, 24 months evaluation
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Time frame: Time Frame: 1,3,6, 12, 24 months evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing injection of autologous bone marrow concentrate and injection of hyaluronic acid. in people with Osteoarthritis, Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC)-Subjective score (time frame: Time Frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.